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NCT02097849 · ClinicalTrials.gov registry record · Phase 2

Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

A Phase 2 study of Relapsing Forms of Multiple Sclerosis, sponsored by Biogen.

Completed
Registry status
Phase 2
Development phase
71
Enrollment target
14
Study locations

NCT02097849 is a Phase 2 study of Relapsing Forms of Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 71 participants. The trial reports 14 study locations across 10 states.

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The verdict

NCT02097849, a Phase 2 study of Relapsing Forms of Multiple Sclerosis, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 2
Development phase
71 participants
Enrollment target
14
Study locations

Study Summary

Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) \[T cell-dependent neoantigen response\].

Interventions

  • DRUG dimethyl fumarate
  • BIOLOGICAL tetanus diphtheria toxoids vaccine
  • BIOLOGICAL 23-valent pneumococcal polysaccharide vaccine
  • BIOLOGICAL meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)
  • DRUG non-pegylated interferon

Study Locations (14)

Ohio

  • Research Site - Akron
  • Research Site - Cleveland
  • Research Site - Dayton

Florida

  • Research Site - Fort Lauderdale
  • Research Site - Sarasota

Texas

  • Research Site - Round Rock
  • Research Site - San Antonio

Arizona

  • Research Site - Gilbert

Colorado

  • Research Site - Thornton

Indiana

  • Research Site - Indianapolis

Kentucky

  • Research Site - Lexington

Maine

  • Research Site - Auburn

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2015-02-28
Est. Completion 2016-05-02
Phase Phase 2

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT02097849

The ClinicalTrials.gov registry entry for NCT02097849 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Relapsing Forms of Multiple Sclerosis appearing as the primary indexed condition, and to 5 interventions - of which dimethyl fumarate is the first listed.

NCT02097849 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Ohio, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT02097849 about?

NCT02097849 is a clinical study titled "Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.". Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objecti...

What is the current status of trial NCT02097849?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2015-02-28. Estimated completion is 2016-05-02.

What conditions does trial NCT02097849 study?

This clinical trial studies the following conditions: Relapsing Forms of Multiple Sclerosis.

What interventions are being tested in trial NCT02097849?

The interventions under investigation include: dimethyl fumarate (DRUG), tetanus diphtheria toxoids vaccine (BIOLOGICAL), 23-valent pneumococcal polysaccharide vaccine (BIOLOGICAL), meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) (BIOLOGICAL), non-pegylated interferon (DRUG).

Who is sponsoring clinical trial NCT02097849?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02097849 being conducted?

This trial has 14 study locations across Arizona, Colorado, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.